Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization

Phase 1

• Conditions: Peripheral Vascular Diseases; Surgical Wound Infection

• Registration Number: NCT02084017
• Lead Sponsor: Western University, Canada

Brief Summary

The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s).

Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector.

The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.

Detailed Description

The study is a non-blinded randomized control trial. The study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (BMI \> 30, previous femoral cut-down). The investigators expected to find a lower surgical site infection rate in patients using the NPWT device.

Patients after giving informed consent will be randomized to receive either NPWT or standard wound therapy following tier lower-limb revascularization operative. Both will be applied under sterile conditions immediately post-operatively. The intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two.

The data will be analyzed with an intention to treat analysis.

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Study Start: 2014-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31
• Primary Completion: 2015-10
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• BMI > 35
• Previous femoral exposure
• Undergoing lower-limb revascularization

Exclusion Criteria

• Cannot obtain seal
• Non-primary wound closure
• Pre-existing infection
• Endovascular repair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	30 days	Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	30 days
Amputation	30 days	Need for amputation post-operatively secondary to infection
Emergency room visits	30 days	Number of times the patient return to the emergency department following discharge from hospital and before the follow-up clinic appointment
Length of stay	Date of discharge	Duration (in days) the patient stays in hospital post-operatively
Re-operation rate	30 days	Need for re-operation following graft failure secondary to infection

Trial Locations

Locations (1)

Victoria Hospital; 🇨🇦 London, Ontario, Canada